In a clinical setting, it is advantageous that medical products, particularly systems formed from multiple separate connecting elements, automatically configure and operate together in a safe and effective manner. It is also beneficial that incorrect or non-approved combinations of system elements are prevented from operating. In addition, it is helpful if the user is provided with feedback on the status of the system configuration.
This is particularly the case in areas of patient care where medical staff are busy with other essential activities, focused on more critical aspects, such as surgical and intensive care activities or where staff have a limited understanding of the operation, and function of the specific medical equipment.
Further, there are many devices found in the healthcare environment that share similar types of fluidic connectors that can be easily mistaken by the user as being compatible. Many similar devices use standard commercially available connectors and tubes and these, therefore, can potentially be a source of confusion to the healthcare professional.
In contrast, it is advantageous to a medical device manufacturer to be able to use a standard size of connection hose on a variety of different garments. This ensures that there is a sufficiently large path provided for fluid flow to allow for a correct inflation. This is also the case when a connector is selected, wherein it is beneficial to have a standard connector type that has a capability to be configured in some manner for product specific use. In particular, being able to maintain the same connector barrel diameter across various products allows for advantages in equipment design and management. For example, in the field of compression garments, these devices often share a standard diameter air tube (e.g. 3/16 inch diameter) and an air connector.
Hence, at first inspection, many different devices appear to be readily compatible between the various different suppliers of garments and pumps. However these devices are often not readily functionally cross-compatible and, as a result, are specifically not licensed or regulatory approved for use in combination. It is also possible that there are patient hazards associated with this inappropriate use, so there is a patient safety benefit to achieve by avoiding the misuse of items in this manner.
Therefore, manufacturers typically try to find methods, often involving subtle design differences involved that can be used to prevent actual misuse or incorrect compatibility—such as mechanical keying, labelling or other more advanced automatic means. However the use of these design differences is not always fully advantageous as they are often not immediately apparent to the user as the connectable items sometime initially appear to partially connect together, but the resulting operation will not be correct.
The various connectors used on similar pumps, and the various mating connectors used on various garments, can all look very similar. So it is relatively easy to mistake which combination of pumps and garments are intended to operate in combination with each other.
It is often the case that equipment is physically set up ready for a patient, in advance of clinical need, wherein the user mistakenly believes the equipment is connected correctly and ready for use. As a result of this error, when the equipment is eventually put into use, possibly by different members of clinical staff, the required therapy will not be delivered and the resulting lack of functionality can result in alarms and warnings generated and, therefore, cause clinical delay and complications.
The automatic detection of the connected garment by a pump can provide a solution to this problem by detecting the presence of a valid connection. This approach is already well known in the prior art, indeed the applicants own patent (e.g. U.S. Pat. No. 6,884,255) provides for such a mechanism using a component built into the fluid connector and this component is automatically detected and identified. This approach provides both positive and negative feedback in both a visible and audible manner regarding the suitability of the garment using the user interface of the pump. However, this approach does require the user to take note of the information being provided on the user interface and is only operational when the pump is powered.